Pharbinex-PE

Manufacturer: Ulai Health LLC
Effective date: 2025-01-20
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-06-01 00:53:21

Label at a glance#

ProductPharbinex-PE

Active ingredientGUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE

Label structure8 sections

Indications and uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus helps to make cough more productive temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies promotes nasal and/or sinus drainage temporarily relieves sinus congestion and pressure

Storage and handling

store at 20 0 - 25 0 C (68 0 -77 0 F)

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact(866) 562-2756

Label contents#

Full prescribing information#

Active ingredients (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Guaifenesin 400mg

Phenylephrine HCl 10mg

Purpose

OTC - PURPOSE SECTION

Expectorant

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus
helps to make cough more productive
temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
promotes nasal and/or sinus drainage
temporarily relieves sinus congestion and pressure

Do not use

OTC - DO NOT USE SECTION

if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

heart disease
high blood pressure
thyroid disease
diabetes
difficulty in urination due to an enlarged prostate gland
cough accompanied by too much phlegm (mucus)
persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

OTC - WHEN USING SECTION

When using this product do not exceed recommended dosage.

Stop use and ask a doctor if

OTC - STOP USE SECTION

nervousness, dizziness or sleeplessness occurs
symptoms do not improve within 7 days, or are accompanied by a fever
cough persists more than 7 days, tends to recur, or is accompanied by a fever, rash, persistent headache

These could be sings of a serious illness.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

take with a full glass of water
this product can be administered without regard for the timing of the meals
do not exceed 6 doses in 24 hours or as directed by a doctor

adults and children 12 years of age and over	take 1 caplet every 4 hours as needed
children 6 to under 12 years of age	take ½ caplet every 4 hours as needed
children under 6 years of age	ask a doctor

Other information

STORAGE AND HANDLING SECTION

store at 20 ⁰- 25 ⁰C (68 ⁰-77 ⁰F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, hypromellose, lactose, magnesium stearate, maltodextrin, microcrystalline celluclose, mineral oil, povidone, silicon dioxide, sodium lauryl sulfate, stearic acid, titanium dioxide, triacetin

Questions or comments?

OTC - QUESTIONS SECTION

(866) 562-2756 (Mon-Fri 8 AM to 4 PM EST)

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Distributed by:

ULAI HEALTH LLC.

Alexandria, VA 22312

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PHARBEST

NDC 73057-389-04

Manufactured in the USA

Immediate Release

PHARBINEX-PE

Guaifenesin 400mg

Phenylephrine HCl 10mg

Expectorant &

Nasal Decongestant

30 CAPLETS

Pharbinex PE Caplet Product Label Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1304111	guaiFENesin 400 MG / phenylephrine HCl 10 MG Oral Tablet	PSN	3
1304111	guaifenesin 400 MG / phenylephrine hydrochloride 10 MG Oral Tablet	SCD	3

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
GUAIFENESIN Pharmacologic Class Indexing	1	Indexing - Pharmacologic Class	20211129
PHENYLEPHRINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
73057-389-04	2022-01-31	C162847	48780-1	d6a99b39-9ec4-a426-e053-dadaa90af4c2	Drug Facts
73057-389-04	2022-01-28	C162847	48780-1	d6a99b39-9ec4-a426-e053-dadaa90af4c2	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
73057-389-04	Pharbinex-PE	30 in 1 BOTTLE, PLASTIC	TABLET, COATED	30		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
73057-389	PHARBINEX-PE (GUAIFENESIN 400MG AND PHENYLEPHRINE HCL 10MG) TABLET, COATED [ULAI HEALTH LLC]	3	Current NDC, Legacy NDC, 1 package rows	20250122_e459bb83-b1d6-42fc-aa46-99ad117e6144.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 19 matching rows.

Pharbinex-PE
GUAIFENESIN 400mg and PHENYLEPHRINE HCL 10MG
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MALTODEXTRIN
CELLULOSE, MICROCRYSTALLINE
MINERAL OIL
POVIDONE K30
POVIDONE K90
SILICON DIOXIDE
SODIUM LAURYL SULFATE
STEARIC ACID
TITANIUM DIOXIDE
CROSCARMELLOSE SODIUM
TRIACETIN
GUAIFENESIN
PHENYLEPHRINE HYDROCHLORIDE
PHENYLEPHRINE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
73057-389	73057-389-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
HYPROMELLOSE, UNSPECIFIED	3NXW29V3WO	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
MALTODEXTRIN	7CVR7L4A2D	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
MINERAL OIL	T5L8T28FGP	IACT
POVIDONE K30	U725QWY32X	IACT
POVIDONE K90	RDH86HJV5Z	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
STEARIC ACID	4ELV7Z65AP	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
CROSCARMELLOSE SODIUM	M28OL1HH48	IACT
TRIACETIN	XHX3C3X673	IACT
GUAIFENESIN	495W7451VQ	ACTIB
PHENYLEPHRINE HYDROCHLORIDE	04JA59TNSJ	ACTIB

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pharbinex-PE	GUAIFENESIN 400MG AND PHENYLEPHRINE HCL 10MG	Ulai Health LLC	e459bb83-b1d6-42fc-aa46-99ad117e6144	2025-01-20		Exact identifier ndc (package): 73057-389-04 ndc (product): 73057-389 ndc11 (package): 73057038904 spl id: 2c2a2804-8a2b-be5d-e063-6394a90a9763 spl set id: e459bb83-b1d6-42fc-aa46-99ad117e6144

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.